Ruxolitinib: Additional Phase III data

Additional data from the double-blind, international Phase III COMFORT-I trial in 309 patients showed that a significantly greater proportion of patients treated with oral ruxolitinib achieved a >=50% improvement in symptom score as measured by the modified MFSAF diary from baseline to week 24 vs. placebo (45.9% vs. 5.3%, p<0.0001). Additionally, ruxolitinib significantly improved total symptom score by 46.1% vs. a 41.8% worsening for placebo (p<0.0001). The partners have an SPA from FDA for the trial. Data will be presented at the American Society of Clinical Oncology meeting in Chicago in June. Incyte plans to submit an NDA to FDA this quarter. Novartis, which has ex-U.S. rights to ruxolitinib, also plans to submit an MAA to EMA this quarter (see BioCentury, Dec. 7, 2009). ...